Tramadol and Pain Sensitization
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered...
Brief Summary
Official Title: “Tramadol and Pain Sensitization”
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: December 2007
Detailed Clinical Trial Description
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
Intervention(s) in this Clinical Trial
- Drug: Tramadol
- to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Outcome Measures for this Clinical Trial
Primary Measures
- Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
- Time Frame: with an induced hyperalgic area
Safety Issue?: Yes
- Time Frame: with an induced hyperalgic area
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy men
- Between 18 and 40 years old
- Written consent given
Exclusion Criteria:
- Concomitant medication
- Tramadol hypersensibility
- Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: University Hospital, Clermont-Ferrand Other
Overall Clinical Trial Officials and Contacts
PICKERING Gisèle, MCU-PH, pharmacology Principal Investigator
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00487175
Study ID Number: CHU63-0020
ClinicalTrials.gov Identifier: NCT00487175
Health Authority: France: Ministry of Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00487175
